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vedolizumab subcutaneousMedica

Crohn’s disease

Initial criteria

  • age ≥ 18 years
  • According to the prescriber, the patient is currently receiving Entyvio intravenous or will receive induction dosing with Entyvio intravenous within 2 months of initiating therapy with Entyvio subcutaneous
  • Patient meets ONE of the following (a, b, c, or d): a) Patient has tried or is currently taking systemic corticosteroids, or corticosteroids are contraindicated in this patient; OR b) Patient has tried one conventional systemic therapy for Crohn’s disease (examples include azathioprine, 6-mercaptopurine, or methotrexate); OR c) Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) Patient had ileocolonic resection (to reduce the chance of Crohn’s disease recurrence)
  • The medication is prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

  • Patient has been established on Entyvio subcutaneous or intravenous for at least 6 months
  • Patient meets at least ONE of the following: a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal lactoferrin, fecal calprotectin, C-reactive protein, MRI/CT enterography, endoscopic assessment, or reduced corticosteroid dose); OR b) Compared with baseline, patient experienced improvement in at least one symptom such as decreased pain, fatigue, stool frequency, and/or blood in stool

Approval duration

initial: 6 months; reauthorization: 1 year